NDC 49483-223 Nitro-time

Nitroglycerin Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
49483-223
Proprietary Name:
Nitro-time
Non-Proprietary Name: [1]
Nitroglycerin
Substance Name: [2]
Nitroglycerin
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Time Cap Laboratories, Inc
    Labeler Code:
    49483
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    06-19-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    PINK (C48328 - PINK)
    WHITE (C48325 - CLEAR)
    BLUE (C48333 - BLUE)
    YELLOW (C48330 - YELLOW)
    GREEN (C48329 - GREEN)
    Shape:
    CAPSULE (C48336)
    Size(s):
    7 MM
    8 MM
    9 MM
    Imprint(s):
    TCL;1221
    TCL;1222
    TCL;1223
    Score:
    1

    Product Packages

    NDC Code 49483-223-06

    Package Description: 60 CAPSULE in 1 BOTTLE, PLASTIC

    NDC Code 49483-223-10

    Package Description: 100 CAPSULE in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 49483-223?

    The NDC code 49483-223 is assigned by the FDA to the product Nitro-time which is a human prescription drug product labeled by Time Cap Laboratories, Inc. The generic name of Nitro-time is nitroglycerin. The product's dosage form is capsule and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 49483-223-06 60 capsule in 1 bottle, plastic , 49483-223-10 100 capsule in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Nitro-time?

    This medication is used to relieve chest pain (angina) in people that have a certain heart condition (coronary artery disease). It may also be used before physical activities (such as exercise, sexual activity) to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates. Angina occurs when the heart muscle is not getting enough blood. This drug works by relaxing and widening blood vessels so blood can flow more easily to the heart.

    What are Nitro-time Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • NITROGLYCERIN 9 mg/1 - A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.

    Which are Nitro-time UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Nitro-time Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Nitro-time?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Nitro-time?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Nitroglycerin Sublingual


    Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). It is also used just before activities that may cause episodes of angina in order to prevent the angina from occurring. Nitroglycerin is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".